Fortrea, a global leader in clinical development and safety science services, is currently inviting applications for the position of Safety Science Coordinator I at its Mumbai location. This full-time opportunity is ideal for fresh graduates or early-career professionals looking to build a career in drug safety and pharmacovigilance.
Safety Science Coordinator I
Position Overview
The Safety Science Coordinator I will assist with critical safety operations associated with clinical trials and post-marketing surveillance. This includes managing and processing adverse events (AEs) and serious adverse events (SAEs), ensuring their accurate documentation and submission to regulatory authorities, ethics committees, and clients—all within defined timelines and quality standards.
Key Responsibilities
- Assist in the processing and reporting of Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs).
- Maintain adverse event tracking systems and documentation.
- Support narrative writing and MedDRA coding of adverse events.
- Perform listedness assessments for marketed products.
- Submit safety reports to relevant stakeholders as required.
- Collaborate with team members to ensure high-quality data management and timely report delivery.
- Participate in reconciliation of safety databases and archiving of study safety files.
- Ensure compliance with company SOPs, regulatory guidelines, and project-specific requirements.
- Provide administrative and operational support to safety science teams.
Eligibility Criteria
Education & Experience:
Candidates should meet one of the following qualifications:
- Non-degree holders with 1–2 years of safety or relevant experience.
- Associate degree holders with 6 months to 1 year of experience.
- Bachelor’s (BS/BA), Master’s (MS/MA), or PharmD holders with up to 1 year of experience in safety science or related areas such as clinical data management, medical affairs, regulatory affairs, or quality assurance.
- BS/BA with 0-6 months to 1 year of Safety experience* or relevant experience**
- MS/MA with 0-6 months of Safety experience* or relevant experience**
- PharmD with 0-6 months of Safety experience* or relevant experience**
Note: A one-year PharmD residency or fellowship is considered valid experience.
Preferred Fields of Study: Biological Sciences, Life Sciences, Pharmacy, Nursing, or Medical Sciences.
Required Skills
- Good team spirit and willingness to support peers.
- Ability to prioritize tasks and multitask in a deadline-driven environment.
- Excellent attention to detail and logical thinking.
- Strong verbal and written communication skills in English and local language.
- Familiarity with Microsoft Office, safety databases, and standard office equipment.
Application Details
- Location: Mumbai
- Job Type: Full-time
- Application Deadline: July 12, 2025
- Job Requisition ID: 253758
About Fortrea
Fortrea is a leading contract research organization (CRO) dedicated to advancing clinical trials and regulatory safety across the globe. Their mission is to deliver life-changing therapies through scientific excellence and strong partnerships with pharmaceutical companies.
If you’re passionate about ensuring drug safety and seeking a role that offers both learning and career growth, this is your opportunity to join an impactful team.
📝 Apply now before July 12, 2025, and be part of the future of global healthcare safety.
